Last updated: 11/07/2018 04:53:59

Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

GSK study ID
112599
See study documents
Clinicaltrials.gov ID
NCT01386983
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
Trial description: This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with clinical progression

Timeframe: 3 months prior to and 12 months following index date

Secondary outcomes:

Dollar amount of enlarged prostate (EP)-related medical costs incurred per month

Timeframe: 3 months prior to and 12 months following index date

Interventions:
  • Drug: 5ARI
  • Drug: 5ARI + AB
    • Enrollment:
    332
    Primary completion date:
    2010-18-03
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Curtis A. Pettaway, Lois E. Lamerato, Michael T. Eaddy, Jessie K. Edwards, Susan L. Hogue, Martin M. Crane . Benign Prostatic Hyperplasia: Racial Differences in Treatment Patterns and Prostate Cancer Prevalence. [BJU Int]. 2011;108(8):1302-8.
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    March 2009 to March 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • Males
    • aged 50 years or older
    • Patients with prostate or bladder cancer
    • any prostate-related surgical procedure within 5 months of index date
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Males
    • aged 50 years or older
    • medical claim of EP
    • prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
    • continuously eligible for 3 months prior to and at least 5 months after their index prescription date.
    Exclusion criteria:
    • Patients with prostate or bladder cancer
    • any prostate-related surgical procedure within 5 months of index date
    • prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-18-03
    Actual study completion date
    2010-18-03

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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